CLASS II Device recall · Reported 22 Feb 2017 · FDA Enforcement Report

The Schiller PB 1000, also known as recalled by Merge Healthcare

Merge Healthcare is recalling The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2, distributed nationwide in the US. The recall was initiated on 31 May 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPatient Data Module (PDM) V2 model: Serial numbers 10.03.XXXXX

Quantity recalled341 sites potentially have the affected product versions

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1203-2017
FDA event ID: 75616
Recalling firm: Merge Healthcare, Hartland, WI
Classification: Class II
Status: Terminated
Recall initiated: 31 May 2015
FDA classified: 15 Feb 2017
Reported: 22 Feb 2017
Type: Voluntary: Firm initiated
Customers notified by: Other
Reason category: Device Malfunction
Device type: Medical Software

Timeline

31 May 2015	Recall initiated by company
15 Feb 2017	Classified by FDA	+626 days
22 Feb 2017	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Non-invasive blood pressure pumps (NIBP) voltage is not sufficient and causes the NIBP pumps to fail prior to reaching adequate initial pressure.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a major component of the Merge Hemo software.

Where it was distributed

Distribution was nationwide to medical facilities. There was also military and government distribution.

Nationwide

Questions about this recall

Why was it recalled?

Non-invasive blood pressure pumps (NIBP) voltage is not sufficient and causes the NIBP pumps to fail prior to reaching adequate initial pressure.

Which lots are affected?

Patient Data Module (PDM) V2 model: Serial numbers 10.03.XXXXX

Where was it sold?

Distribution was nationwide to medical facilities. There was also military and government distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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